CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Clopidogrel +1 moredrug
Likely dose
Clopidogrel 75 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01341600
NCT01341600N/ACompleted
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Clopidogrel Pharmacogenetics Bench to Bedside - A Practical Application

University of Maryland, Baltimore·interventional·Posted Apr 25, 2011·Updated Jan 30, 2024

In Brief

A clinical study evaluating Clopidogrel and Omeprazole/Clopidogrel for Metabolism of Clopidogrel. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism of Clopidogrel
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA), National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2011
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.2 years ago

Interventions

Clopidogreldrug

Over a 6 week period participants will be given: 75 mg of clopidogrel for 8 days, at least 1 week washout, 150 mg of clopidogrel for eight days, at least 1 week washout, 300 mg of clopidogrel for eight days.

Omeprazole/Clopidogreldrug

After a washout of at least 1 week, participants will have the option to participate in a final intervention in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days.